This is to advise you that the Food and Drug Administration (FDA) has reviewed your websitesat the intemet address, www.theformulation.com and www.scientificformulations.com, inSeptember 2010. FDA has determined the products NAC Supplement, Antioxidant Supplement,Anti-Angiogenesis Supplement, and Immune Enhancement Supplement are promoted forconditions which cause the products to be drugs under Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on these websites establish the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims violates the Act. You may find the Act and FDA's regulations through links on FDA's Internethome page at http://www.fda.gov.

• "Research has shown that high doses of antioxidants can have anti-cancer benefits."• " Resvida [an ingredient in your product], very high potency Resveratrol (antioxidant)...In vitro Resveratrol has been shown to have positive effects on the cells of breast, skin,gastric, colon, esophageal, prostate, and pancreatic cancer, and leukemia."

Anti-angiogenesis Supplement

• "Scientific Formulation's Anti-Angiogenesis... anti-tumor supplement ..."• "Research shows that both of these primary active ingredients, curcumin and genistein,have these anti-tumor biomechanisms."• "Genistein's [an ingredient in your product] antioxidant and tumor suppressionproperties, particularly for breast and prostate cancer, have been well researched."

Your www.theformulation.com website also contains disease claims in the form of personaltestimonials, including:

• "I was diagnosed with rectal cancer three years ago with metastases to the liver.... TheFormulation was my only option, which I believe contributed to my liver tumors disappearing and my general well-being."• "After I completed surgeries, chemotherapy, and radiation for Stage III breast cancer, my oncologist couldn't assure me that my cancer wouldn't return... I... started taking many of the supplements in the Immune Formulation... Within 30 days of starting on my high potency regimen of supplements. my tumor marker tests have been in the normal range."• "[M]y wife had four recurrences since being diagnosed in 1996 with Stage IIIMelanoma... She was put on the Formulation components with tetrathiomolybdate forantiangiogenesis and has not had a recurrence in the past eight years."• "[T]he doctor discovered a tumor on the outer fold of my stomach.... When we found"The Formulation" ...we made the decision to get it. When the tumor was removed welearned that it had shrunk by 50%, and that was in just 90 days.... My husband and I areso thankful to have found such a successful treatment. We... recommend The Formulation to everyone we know who is battling cancer."

• "However, the importance of the components of The Formulation. which also includesdirect cancer cytotoxicity. may be considered for the prevention of cancer and as a firstline treatment regardless of the anatomic site in the near future."

On the webpage entitled "Overview of the Formulation Components":

• "The 13 components listed above [ingredients in the product] are the result of extensiveresearch to determine the optimum components that would support major pathways-...including direct cytotoxicity against cancer and viral infected cells."

On the webpage regarding the component Alpha Lipoic Acid:

• "The antioxidant Alpha Lipoic Acid (ALA) ...has been shown to posses [sic] promisinganti-cancer activity because of its ability to ...inhibit proliferation of cancer cells...."

• "In addition, NAC has been found to be safe and< [sic] efficacious in the clinic fortreating acute respiratory distress and inflammation, as well as being a useful antidote foracute drug intoxication, e.g. Tylenol (Betten, et al. 2007)."• "Treats Tylenol Overdose"

On the webpage regarding the component Resveratrol:

• "Resveratrol is known to have potent anti-inflammatory and antioxidant effects and toinhibit... the growth of a variety of cancer cells."

On the webpage regarding the component Vitamin B6:

• "This vitamin prevents nervous and skin disorders, provides protection against a highcholecterol [sic] level, certain types of heart disease, and diabetes. It prevents toothdecay."• "Vitamin B6 is now considered as a wonder treatment for a wide range of commonailments, such as diabetes, haemorrhoids, convulsions in infants and women... andinsomnia..."

On the webpage regarding the component Vitamin E:

• "It [vitamin E] is important in the treatment of many cancers including throat, esophagus, stomach, colon, cervix, breast and the prostate gland."

Your products are not generally recognized as safe and effective for the above referenced usesand therefore, the products are "new drugs" under Section 201(P) of the Act [21 U.S.C.§ 321(P)]. New drugs may not be legally marketed in the U.S. without prior approval from FDAas described in Section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on thebasis of scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective.

Furthermore, because your products are offered for conditions which are not amenable to self diagnosis and treatment by individuals who are not medical practitioners, adequate directionscannot be written so a layman can use the products safely for their intended uses. Thus, theirlabeling fails to bear adequate directions for their intended uses, causing them to be misbrandedunder Section 502(f)(1) of the Act, 21 U.S.C. § 352(t)(1). The introduction of a misbrandeddrug into interstate commerce is a violation of § 301(a) of the Act, 21 U.S.C. § 331(a).

The above violations are not meant to be an all-inclusive list of deficiencies in your products andtheir labeling. It is your responsibility to ensure all of your products are in compliance with thelaws and regulations enforced by FDA. You should take prompt action to correct the violations.Failure to promptly correct these violations may result in regulatory actions without furthernotice, such as seizure and/or injunction.

Please notify FDA, in writing, within fifteen (15) working days of the receipt of this letter, as tothe specific steps you have taken to correct the violations noted above and to ensure similarviolations do not occur. Include any documentation necessary to show corrections have beenachieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be directed to, Rebecca A. Asente, Compliance Officer, U.S. Food andDrug Administration. If you have any questions regarding any issues in this letter, please contactMs. Asente at the address above or telephone 504-219-8818 extension 104.

In addition, FTC strongly urges you to review all claims for your products and ensure thoseclaims are supported by competent and reliable scientific evidence. Violations of the FTC Actmay result in legal action seeking a Federal District Court injunction or Administrative Ceaseand Desist Order. An order also may require you pay back money to consumers. Please notifyFTC, via electronic mail at healthproducts@ftc.gov, within fifteen (15) working days of receiptof this letter of the specific actions you have taken to address FTC's concerns. If you have anyquestions regarding compliance with the FTC Act, please contact Richard Cleland at 202-326-3088.